Kornimate/medical-research-clean huggingface dataset:
shark cartilage in treating patients with advanced colorectal or breast cancer

Conditions: Breast Cancer; Colorectal Cancer

Summary: rationale: shark cartilage extract may help shrink or slow the growth of colorectal cancer or breast cancer cells. purpose: randomized phase iii trial to determine the effectiveness of shark cartilage in treating patients who have advanced colorectal cancer or advanced breast cancer.

objectives: * determine whether the addition of powdered shark cartilage (benefin™) to standard therapy improves overall survival in patients with advanced colorectal or breast cancer. * determine whether this therapy has any impact on toxicity in these patients. * determine whether this therapy improves the quality of life in these patients. outline: this is a randomized, double-blind, placebo-controlled, multicenter study. patients are stratified according to disease type (breast vs colorectal female vs colorectal male), age (49 and under vs 50-69 vs 70 and over), ecog performance status (0-1 vs 2), baseline quality of life (uniscale rating less than 50% vs 50-75% vs more than 75%), and concurrent chemotherapy (yes vs no). patients are randomized to 1 of 2 treatment arms.

Eligibility criteria:
disease characteristics: * breast or colorectal primary tumor sites * considered incurable * breast cancer patients must have disease progression after at least 2 different chemotherapy regimens (may include chemotherapy given as an adjuvant treatment) patient characteristics: age: * 18 and over sex: * male or female performance status: * ecog 0-2 life expectancy: * more than 3 months hepatic: * bilirubin no greater than 3 times upper limit of normal (uln) renal: * calcium less than 1.2 times uln other: * not pregnant or nursing * fertile patients must use effective contraception prior concurrent therapy: chemotherapy: * concurrent chemotherapy allowed * no concurrent participation in a cytotoxic chemotherapy clinical trial other: * at least 60 days since prior shark cartilage

Keywords: stage iv colon cancer stage iv breast cancer recurrent breast cancer stage iv rectal cancer recurrent colon cancer recurrent rectal cancer male breast cancer
effectiveness of peerelease - a gel absorbent pad in moderate to severe urinary incontinence

Conditions: Urinary Incontinence

Summary: the purpose of the proposed study is to test the effect of the new gel pad on the quality of life of urinary incontinent men and women and to assess to what extent the gel pad improves the quality of life of incontinence persons.

the devices available today on the market serve two polar incontinence conditions: those who have severe urinary incontinence and need to use diapers several times per day, or those who have mild urinary incontinence and can use pads. such circumstances call for a search of new solution that may provide the benefit of freeing those with moderate incontinence from changing pads several times a day or staying constantly very near a bathroom, as well as freeing those with severe incontinence from using cumbersome diapers. a larger gel containing pad was developed, suitable to absorb up to half a litter liquid, it eliminates odors and enables the users to wear ordinary clothes . it was presented for clinical trial. the objectives of the clinical trial, proposed hereafter is to assess to what extent the new gel pad presents an advantage over the existing means of coping with urinary incontinence in cases when medicinal treatment or surgery is not appropriate.

Eligibility criteria:
inclusion criteria: 1. urinary incontinent women and men who loose urine at a quantity higher than drops (50cc or more). 2. three segments of such persons will be included in the study: * pregnant women who are temporary urinary incontinent * women of the age 40+ who are urinary incontinent * men who are urinary incontinent (post prostatectomy) exclusion criteria: 1. urinary incontinent disabled patients who need nursing 2. patients who presently have cancer of any kind,

Keywords: urinary incontinent
study of pyx-201 in solid tumors

Conditions: Solid Tumor; Advanced Solid Tumor

Summary: the primary objectives of this study are to determine the recommended dose(s) of pyx-201 for participants with relapsed/refractory (r/r) solid tumors, and to determine the objective response rate (orr) in participants treated with pyx-201 as a single agent.


Eligibility criteria:
inclusion 1. histologically or cytologically confirmed solid tumors including locally advanced/metastatic nsclc, hr+ and her2- breast cancer, hr- and her2-positive breast cancer, tnbc, hnscc, ovarian cancer, thyroid cancer, pancreatic ductal adenocarcinoma (pdac), sarcomas, hepatocellular carcinoma (hcc), kidney cancer, cervical cancer and endometrial cancer. 2. male or non-pregnant, non-lactating female participants age ≥18 years. 3. eastern cooperative oncology group (ecog) performance status (ps) of 0 to 1. 4. participant must have at least 1 measurable lesion per response evaluation criteria in solid tumors (recist) v1.1. 5. life expectancy of \>3 months, in the opinion of the investigator. 6. corrected qtcf \<470 msec. 7. adequate hematologic function. 8. adequate hepatic function. 9. adequate renal function. 10. adequate coagulation profile. 11. clinical sites must conduct fresh tumor biopsy or provide participant's archived tumor tissue sample. exclusion 1. history of another malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin; in situ cervical carcinoma; adequately treated, noninvasive bladder cancer. 2. known symptomatic brain metastases. 3. significant cardiovascular disease within 6 months prior to start of study drug. 4. evidence of an active systemic bacterial, fungal, or viral infection requiring treatment at the start of study drug. 5. known active hepatitis b virus (hbv), hepatitis c virus (hcv), human immunodeficiency virus (hiv) or acquired immunodeficiency syndrome (aids). 6. failure to recover to baseline severity or grade ≤1 nci-ctcae v5.0 from acute non-hematologic toxicity. 7. participants with nci-ctcae v5.0 grade \>1 neuropathy of any etiology. 8. prior solid organ or bone marrow progenitor cell transplantation. 9. prior high-dose chemotherapy requiring stem cell rescue. 10. received systemic anticancer therapy within 28 days or within 5 half-lives (whichever is shorter) prior to the start of study drug. 11. palliative radiation therapy within 14 days prior to the start of study drug. 12. previously received extra domain b splice variant of fibronectin (edb+fn) targeting treatments at any time prior to the start of pyx-201 treatment. 13. history of uncontrolled diabetes mellitus. 14. history of stevens-johnson syndrome or toxic epidermal necrolysis. 15. participants with corneal epithelial disease, with the exception of mild punctate keratopathy 16. participants with the best-corrected visual acuity in the worst-seeing eye worse than 20/100 (snellen equivalent).

Keywords: relapsed/refractory solid tumor pyx-201
effect of exercise training on salivary immunoglobulin a in patients with chronic obstructive pulmonary disease

Conditions: COPD

Summary: the purpose of this study is to determine whether whole body exercise training alters the immunity in the lungs of people with copd and reduces the incidence of chest infections over the longer term.

patients will undertake an 8 weeks pulmonary rehabilitation program of exercise and education. those who decline to take part in pulmonary rehabilitation will have the same outcome measures collected at the same timepoints.

Eligibility criteria:
inclusion criteria: * diagnosis of copd (fev1/fvc \< 70), smoking hx of minimum of 10 pack years exclusion criteria: * diagnosis of asthma, bronchiectasis, attendance at pulmonary rehabilitation within last 12 months, exacerbation of copd within last 4 weeks

Keywords: copd, pulmonary rehabilitation, airway immunity
assessment of ins1007 in participants with non-cystic fibrosis bronchiectasis

Conditions: Non-Cystic Fibrosis Bronchiectasis

Summary: the purpose of the study is to evaluate if ins1007 can reduce pulmonary exacerbations over a 24-week treatment period in participants with non-cystic fibrosis bronchiectasis.

phase 2 randomized, double-blind, placebo-controlled, parallel-group, multicenter, multi-national study to assess the efficacy, safety and tolerability, and pharmacokinetics (pk) of ins1007 administered once daily for 24 weeks in participants with non-cystic fibrosis bronchiectasis (ncfbe).

Eligibility criteria:
inclusion criteria: 1. clinical history consistent with ncfbe (cough, chronic sputum production and/or recurrent respiratory infections) 2. are current sputum producers with a history of chronic expectoration and able to provide a sputum sample during screening 3. have at least 2 documented pulmonary exacerbations in the past 12 months before screening exclusion criteria: 1. have a primary diagnosis of chronic obstructive pulmonary disease (copd) or asthma 2. have bronchiectasis due to cystic fibrosis (cf), hypogammaglobulinemia, common variable immunodeficiency, or alpha1-antitrypsin deficiency 3. are current smokers 4. are currently being treated for a nontuberculous mycobacterial lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis 5. have any acute infections, (including respiratory infections)

Keywords: p aeruginosa bronchiectasis active neutrophil elastase
anal motor function in fecal incontinence

Conditions: Fecal Incontinence

Summary: traditionnal measurment of anorectal function is perfomed with manometric device using 2 to 3 pressure sensors. the investigators aim to evaluate the usefulness of high resolution manometry to measure anorectal motility

measurment of anorectal function is traditionnaly made using manometric device composed of perfused or ballon catheters. this allows the recording of anorectal pressure on 2-3 sites. recently, high resolution manometryu devices using \> 36 pressure channels have been developped. the investigators therefore aim to evaluate the usefullness of the high resolution manometry in patient with fecal incontinence in terms of feasability and diagnosis accuracy

Eligibility criteria:
inclusion criteria: * patient with fecal incontinence (group "fecal incontinence" * subject without significant medical or surgical hisotry (group healthy controls) exclusion criteria: * pregnacy * unable to speack/understand french language * not affilitated to the french healthcare system * history of anorectal disease (for the group of healthy controls) including fecal incontinence, or protocologic surgery * constipation * diarrhea

Keywords: fecal incontinence, ano-rectal manometry
regulation of lipoprotein metabolism in obese men

Conditions: Obesity; Dyslipidemia; Insulin Resistance

Summary: visceral obesity is strongly associated with dyslipidaemia (hypertriglyceridaemia, low hdl-cholesterol and mildly elevated ldl-cholesterol) and insulin resistance, key characteristics of metabolic syndrome (mets). recent evidence has clearly established that the risk of cvd is increased in subjects with the mets. the precise reason for this remains unclear, but appears to be closely related with dyslipidaemia. effective management of dyslipidaemia is important to reduce the risk of cvd in these subjects. hypothesis: inhibition of hepatic cholesterol synthesis by statins and triglyceride synthesis by fish oils improve lipoprotein metabolism in visceral obese men.

the study employed a factorial study design, stable isotopy and mathematical modelling to examine the independent and combined effects of decreasing cholesterol substrate availability with atorvastatin and decreasing triglyceride substrate availability with fish oils on lipoprotien kinetics (apob, apoa, apoc-iii and chylomicron remnants) in insulin-resistant men with visceral obesity.

Eligibility criteria:
inclusion criteria: * obesity was defined as a waist circumference \>100 cm, waist:hip ratio \>0.97 and bmi \>29 kg/m2. * subjects were selected for having insulin-resistance, defined as a homostasis model assessment (homa) score (21) \>5.1 (i.e. one sd above the mean for a reference population of 22 lean, normolipidemic healthy males of similar age). * all subjects had plasma triglyceride \>1.2 mmol/l and cholesterol \>5.2 mmol/l at screening while consuming ad libitum, weight-maintaining diets exclusion criteria: * diabetes mellitus, apolipoprotein e2/e2 genotype, macroproteinuria, creatinemia, hypothyrodism, or abnormal liver enzymes. * subjects did not consume fish oil supplements or drank more than 30g alcohol/day. * none reported a history of cvd, or was taking medication or other agents known to affect lipid metabolism.

Keywords: lipoprotein metabolism cardiovascular disease obesity
effect of influenza vaccination on ivf outcomes - ivf

Conditions: Infertility

Summary: in this study the investigators propose a randomized controlled trial to evaluate the effect of influenza vaccination on clinical pregnancy rates among women undergoing in vitro fertilization.

since 2004 flu vaccination has been recommended by american college of obstetricians and gynecologists (acog) advisory committee on immunization practices (acip) for all pregnant women during flu season, regardless of the trimester of pregnancy. many studies have examined the safety of influenza vaccination and found benefits beyond the simple prevention of maternal infection including the reduction of still birth. recently evidence has emerged that women who have received a flu vaccination were less likely to experience premature labor. the investigators hypothesize that some of the maternal benefits of influenza vaccination might be based on other than prevention of the flu, possibly secondary to the induction of immune system pathways that favor immunological tolerance. induction of immune system pathways that favor immunological tolerance has long been considered a possible path to improved embryo implantation and reduce miscarriages, though the topic is still somewhat controversial. patients undergoing ivf will be randomized in two strata: 1. history of recurrent miscarriage or implantation failure 2. no history of recurrent miscarriage of implantation failure consenting patients will be randomized to receive either influenza vaccine or a saline placebo. vaccination will occur 10 days before initiating anticipated menses or fertility treatment cycle start. all patients will be receiving an offered a second injection at the time of negative pregnancy test or at the time of sign-out with a clinical pregnancy. the second injection will either be placebo or influenza vaccination depending on the original randomization. patients and clinical staff will remain blinded to the original treatment assignment, except for the study coordinator and the single staff member assigned to administer the injection.

Eligibility criteria:
inclusion criteria: 1. all women preparing to undergo an ivf cycle 2. women will only be allowed to participate in one treatment cycle 3. willingness to have an influenza vaccination 4. signed informed consent exclusion criteria: 1. any contraindication for flu vaccination 2. unwillingness to have a flu vaccination 3. unwillingness to sign informed consent 4. previous diagnosis of unfavorable endometrial development 5. unresolved uterine condition that significantly compromises the endometrial cavity

Keywords: immunology pregnancy implantation rate fertilization in vitro
magnesium prophylaxis for the prevention of new-onset atrial fibrillation in critically ill patients

Conditions: Critical Illness; New Onset Atrial Fibrillation

Summary: a double-blind, multi-centre, randomized, placebo-controlled, feasibility pilot trial in the prevention of new onset atrial fibrillation of critically ill patients admitted to an icu.

most studies of new onset atrial fibrillation (noaf) in critical illness focus on treatment of this arrhythmia but this innovative study will focus on prevention. parenteral mg is a low cost and readily available treatment that may be beneficial for reducing the incidence of noaf in critically ill patients, with the potential to improve patient centred outcomes and provide a cost effective prophylaxis. the main outcome of this study is to determine if it is feasible to conduct a randomized controlled trial comparing parenteral magnesium sulfate with placebo for the prophylaxis of new onset atrial fibrillation in critically ill patients.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. admitted to a critical care unit with either: 1. non-invasive ventilation (including high flow nasal canula) or invasive mechanical ventilation with an expected duration \>24 hours and/or 2. vasopressor or ionotropic support for shock of any etiology. shock is defined by the need for one of the following vasopressors/inotropes: dopamine dobutamine norepinephrine epinephrine ephedirine milrinone at any dose (if used in conjunction with another agent) vasopressin (if used in conjunction with another agent) 3. receiving continuous cardiac monitoring. exclusion criteria: 1. active atrial fibrillation prior to randomization or pre-existing (permanent or paroxysmal) atrial fibrillation 2. unlikely to survive \>24 hours or palliative patients 3. cardiac surgery patients 4. patients requiring parenteral magnesium therapy (e.g. pre-eclampsia, asthma) 5. patients receiving dialysis 6. positive pregnancy test 7. previously enrolled in this trial 8. treating physician refuses enrollment 9. receiving icu intervention (non-invasive ventilation including high flow nasal canula, invasive mechanical ventilation or ionotropic support) for \>18h hours

Keywords: prophylaxis prevention
computer-assisted provision of reproductive health care

Conditions: Contraception; Sexually Transmitted Diseases

Summary: this project seeks to demonstrate that computer kiosks in a clinic waiting room can improve access to hormonal contraception and screening for sexually transmitted infections. the study will be a randomized controlled trial which will evaluate the use of a computer kiosk module to compare the proportion of women of reproductive age who receive a prescription for hormonal contraception when computer-assisted provision of hormonal contraception is offered (intervention) to encounters when the study clinic provides standard contraceptive care (control). subjects will be contacted approximately 3 months (range 2-4 months) after the clinic visit to complete a follow-up phone interview. the study population will include english and spanish-speaking women ages 18-45 who seek care at this clinic. our hypothesis is that computer-assisted provision of hormonal contraception (intervention)will increase the proportion of women of reproductive age who receive a prescription for hormonal contraception versus standard contraceptive care(control).

data collection has been completed

Eligibility criteria:
inclusion criteria: * women who speak english or spanish who visit a study clinic exclusion criteria: * women who do not speak english or spanish

Keywords: contraception sexually transmitted diseases
cardiac power output in cardiogenic shock patients

Conditions: Heart Failure; Cardiogenic Shock

Summary: the main purpose of this study is to determine whether differences in myocardial reserve predict clinical outcomes for heart failure patients.

this study is designed as a prospective, observational, crossover study to assess the feasibility of using differences in invasive hemodynamics of cardiac function, representing myocardial reserve, to predict clinical outcomes for heart failure patients. patients with heart failure referred for right heart catheterization (rhc) by the advanced heart failure team as part of 1) evaluation for advanced heart failure therapies, including left ventricular assist device (lvad), orthotopic heart transplant (oht), temporary or long-term inotrope therapy, or counter-pulsation (temporary intra-aortic balloon pump (iabp) or long-term with nupulse device), 2) for accurate assessment of invasive hemodynamics due to worsening clinical status, 3) assessment of myocardial recovery for consideration of lvad or nupulse decommissioning or removal or mechanical circulatory support removal, or 4) accurate assessment of cardiac function in patients with reduced lvef prior to valve replacement for aortic insufficiency (ai) or mitral regurgitation (mr).

Eligibility criteria:
inclusion criteria: 1. lvef ≤ 40% 2. referred for rhc for: 1. evaluation for advanced heart failure therapies, including lvad, oht, temporary or long-term inotrope therapy, or counter-pulsation (temporary or long-term with nupulse device or 2. accurate assessment of invasive hemodynamics due to worsening clinical status, or 3. assessment of myocardial recovery for consideration of lvad or counter-pulsation (temporary iabp or long-term with nupulse device) decommissioning or removal or 4. assessment of cardiac function and valvular abnormalities prior to planned valvular surgery for mr or ai 3. estimated glomerular filtration rate (egfr) ≥ 30 ml/min/1.73 m2 4. age ≥ 18 years-old 5. intent for admission based on rhc data exclusion criteria: 1. egfr \< 30 ml/min/1.73 m2 2. severe, non-revascularized coronary artery disease 3. concurrent acute coronary syndrome 4. age \< 18 years-old 5. history of significant ventricular arrhythmia without an icd
dysport® pediatric lower limb spasticity study

Conditions: Cerebral Palsy; Muscle Spasticity; Children

Summary: the purpose of this research study is to determine whether dysport® is effective in the treatment of increased stiffness of the calf muscles and to evaluate the safety of this treatment in children with cerebral palsy. in addition this study will also check whether dysport® can lessen the pain caused by spasticity and improve the child's wellbeing.


Eligibility criteria:
inclusion criteria: * children aged 2 to 17 years with cerebral palsy * equinus foot position * ambulatory * intensity of muscle tone equal to or greater than 2 in affected lower limb, as measured on the modified ashworth scale exclusion criteria: * fixed contracture * previous phenol, alcohol injection or surgical intervention * other neurological / neuromuscular disorder * severe athetoid or dystonic movements